Pamorelin

Palliative treatment of locally advanced, non-metastatic hormone-dependent prostate cancer, as alternative to surgical castration. Metastatic hormone-dependent prostate cancer. Adjuvant treatment to RT in patients w/ high-risk localized or locally advanced prostate cancer. 3.75 mg: Adjuvant treatment, in combination w/ tamoxifen or aromatase inhibitor, of hormone receptor +ve early stage breast cancer in women at high risk of recurrence who are confirmed as premenopausal after completion of chemotherapy. Pituitary down-regulation in context of assisted reproduction technology. 3.75 mg & 11.25 mg: Endometriosis. 22.5 mg: Central precocious puberty (CPP) in childn ≥2 yr w/ onset of CPP before 8 yr in girls & 10 yr in boys.

Prostate cancer 3.75 mg 1 IM inj or 1 SC inj every mth (4 wk). 11.25 mg 1 IM inj every 3 mth (12 wk). 22.5 mg 1 IM inj every 6 mth (24 wk). Breast cancer 3.75 mg 1 IM inj once a mth (ie, every 4 wk) in combination w/ tamoxifen or aromatase inhibitor. Commence after completion of chemotherapy, once premenopausal status has been confirmed. Initiate treatment at least 6-8 wk before starting aromatase inhibitor treatment. Administer min of 2 inj (w/ interval of 4 wk between inj) before commencement of aromatase inhibitor treatment. Recommended treatment duration for adjuvant treatment in combination w/ other hormonotherapy: Up to 5 yr. Pituitary down-regulation in context of assisted reproduction technology 3.75 mg Long protocol: 3.75 mg as single inj prior to induction of stimulation w/ exogenous gonadotropins. Measure extent of pituitary suppression by level of circulating estrogens. Only induce stimulation w/ exogenous gonadotropins when E₂ levels is <50 pg/mL. Short protocol: Induce stimulation w/ exogenous gonadotropins at the same time as, or very shortly after, 3.75 mg as single inj. Endometriosis 3.75 mg Single IM or SC inj every 28 days, to be initiated in 1st 5 days of menstrual cycle. Max duration of treatment: 6 mth. Precocious puberty 22.5 mg Childn Individualized dosage. Administer 22.5 mg as precisely as possible in regular 6 mthly (24 wkly) periods, respectively.

Hypersensitivity to triptorelin, GnRH, LH releasing hormone, GnRH agonist analogs. Patients w/ spinal cord compression secondary to prostate cancer metastases. Initiation of aromatase inhibitor before achieving adequate ovarian suppression in pre-menopausal breast cancer setting. Women w/ undiagnosed abnormal vag bleeding. Pregnancy & lactation.

Routinely monitor patients by appropriate physical exam & lab tests during treatment. Transient increase in serum testosterone levels at initial phase of therapy. Not recommended in retreatment for endometriosis. Rule out pseudo-precocious puberty (eg, gonadal or adrenal tumor or hyperplasia) & gonadotropin-independent precocious puberty (eg, testicular toxicosis, familial Leydig cell hyperplasia) before starting therapy. Confirm premenopausal status, irrespective of menstrual status, after chemotherapy & before starting therapy by obtaining blood estradiol & FSH conc w/in reference ranges for pre-menopausal women in order to avoid chemotherapy-induced menopause. Confirm adequate ovarian suppression (gonadotropin analog-induced menopause) following initiation of treatment in subset of women considered for therapy w/ aromatase inhibitor. Repeat measurements every 3 mth during combination therapy w/ aromatase inhibitor to avoid aromatase inhibitor-induced rebound increase in circulating estrogen, w/ consequential implications for w/ breast cancer. Endocrine/metabolic effects. Bone mineral density loss. High risk of osteoporosis when used as adjuvant therapy in combination w/ tamoxifen or aromatase inhibitor. Patients w/ established osteoporosis or risk factors for decreased bone mineral content &/or bone mass eg, chronic alcohol abuse, smokers, long-term therapy w/ drugs that reduce bone mineral density (eg, anticonvulsants, corticoids), family history of osteoporosis, malnutrition (eg, anorexia nervosa). Hyperglycemia & increased risk for development of DM. Monitor blood glucose &/or HbA1c periodically. Suppression of pituitary gonadotropins & gonadal hormone production w/ clinical manifestations of hypogonadism in long-term administration in therapeutic doses; vag bleeding; ovarian cysts. Discontinue treatment immediately if anaphylactic shock, hypersensitivity, & angioedema develop. Metastatic vertebral lesions & urinary tract obstruction. May increase risk of certain CV diseases (eg, MI, sudden cardiac death & stroke) in prostate cancer patients. Potential to prolong QT/QTc interval on ECG. Hematologic effects eg, anemia as physiologic consequence of testosterone suppression & increased lymphocyte count in patients treated w/ GnRH agonists. Pituitary apoplexy; convulsions; mood changes & depression; ovarian hyperstimulation. Use non-hormonal methods of contraception during therapy until menses resume. May impair fertility in males of reproductive potential. Contains Na <1 mmol (23 mg)/vial. May impair reflexes & ability to drive &/or use machines. Renal & hepatic impairment. Childn <2 yr; w/ progressive brain tumors. Fetal or neonatal morbidity & mortality. Elderly.

Abnormalities in lab values (ie, decreased Hb & RBC counts; & increased glucose, BUN, ALT, AST, & alkaline phosphatase levels). Men: Induced variation in serum testosterone levels including hot flushes, erectile dysfunction, & decreased libido. Women: Hot flushes, vag dryness, amenorrhea.

Concomitant use w/ drugs affecting pituitary secretion of gonadotropins. Efficacy may be reduced w/ drugs that induce hyperprolactinemia eg, antipsychotic agents (chlorpromazine, haloperidol, molindone, olanzapine, prochlorperazine, risperidone), methyldopa, metoclopramide, reserpine. Concomitant use w/ drugs that prolong QTc interval & induce Torsades de pointes including class IA (eg, quinidine, disopyramide), class III (eg, amiodarone, sotalol, dofetilide, ibutilide, dropedarone), or class IC (eg, flecainide, propafenone) antiarrhythmic drugs; antipsychotics (eg, chlorpromazine); antibiotics & analogues (eg, erythromycin, clarithromycin, azithromycin); quinolones (eg, moxifloxacin); antimalarials (eg, quinine); azole antifungals; 5-hydroxytryptamine (5-HT₃) receptor antagonists (eg, ondansetron); methadone, & β-2 adrenoceptor agonists (eg, salbutamol). Potential risk of hematoma at inj site in patients treated w/ anticoagulants. Adjustments of antihypertensives in patients on therapy. Diagnostic tests of pituitary-gonadal function conducted during treatment & w/in 4-12 wk after cessation of therapy may be misleading.

Cancer Hormone Therapy / Trophic Hormones & Related Synthetic Drugs

L02AE04 - triptorelin ; Belongs to the class of gonadotropin releasing hormone analogues. Used in endocrine therapy.

Rx